FDA panel favors expansion of stomach band surgery

WASHINGTON 
A panel of federal health experts on Friday recommended expanding approval of a stomach-shrinking band to help patients who are obese but lighter than patients currently recommended to receive the implant.

The Food and Drug Administration panel voted 8-2 that benefits of Allergan's Lap-Band exceed its risks when used in patients who are not morbidly obese.

The vote comes as the U.S. faces an obesity epidemic encompassing nearly 35 percent of adults and consuming billions of health care dollars each year to treat diabetes, heart disease and other complications.

Shares of Irvine, Calif.-based Allergan Inc. shares rose 52 cents to $68.80 on Friday. In aftermarket trading, they picked up $2.20, or 3.2 percent, to $71.

The company's vice president for clinical research, Dr. Frederick Beddingfield, said in a statement the vote reflects "consensus that there is a need for additional, effective treatment options for patients who are currently obese."

More than a third of all American adults are obese. About 15 million of them meet criteria for gastric banding surgery under current guidelines, which say a person should have a body mass index of 40 or higher, or a BMI of 35 or higher if the person suffers from a weight-related medical problem such as diabetes or high blood pressure.

If adopted, the proposal would lower the Lap-Band requirement to a BMI of 35 or higher, or as low as 30 if the patient has one related problem.

Doing so would increase the number of eligible patients to 27 million, according to federal health data.

The adjustable band has been available in the U.S. since 2001 but far longer in Europe and Australia. A ring is placed over the top of the stomach and inflated with saline to tighten it and restrict how much food can enter and pass through the stomach.

The device was developed as an alternative to gastric bypass surgery, a permanent procedure in which food is rerouted from a pouch in the stomach to the small intestine.

There were about 220,000 gastric surgeries last year, with banding accounting for an estimated 40 percent of that number. Surgeons say the fact that the procedure is reversible and relatively low-risk accounts for its growing popularity.

Despite that popularity, the Lap-Band still faces hurdles to increased adoption, particularly its cost. The surgery usually runs in the range from $14,000 to $20,000, with the device itself accounting for about $3,000.

Susquehanna International analyst Gary Nachman projects a modest 8 percent rise in Allergan's gastric banding business through 2014 to about $258 million.